Human Psychopharmacology of Salvinorin A

This study is characterizing the subject-rated and behavioral effects of salvinorin A in healthy volunteers. The investigators hypothesize the salvinorin A will have hallucinogen-like effects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Salvinorin A

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Behavioral Pharmacology Research Unit
    • Baltimore, Maryland, United States, 21224
      • Behavioral Pharmacology Research Unit, Johnson Hopkins Univ. School of Med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have given written informed consent
• Have a high school level of education
• Have a self-reported interest in spirituality and altered states of consciousness
• Have used hallucinogens (e.g., LSD, psilocybin mushrooms, Salvia divinorum) including having used Salvia divinorum or salvinorin A by the inhalation route (i.e., volunteers without histories of Salvia divinorum or salvinorin A use by the inhalation route will be excluded)
• Be 21 to 65 years old
• Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the volunteer does not routinely consume caffeinated beverages, he or she must agree not to do so on session days.
• Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of each drug administration. As described elsewhere, exceptions include daily use of caffeine.
• Be healthy as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocarroutine medical blood and urinalysis laboratory tests.

Exclusion Criteria:

General Medical Exclusion Criteria

• Cardiovascular conditions: uncontrolled hypertension, angina, a clinically significant ECG abnormality (e.g. atrial fibrillation), TIA in the last 6 months stroke, peripheral or pulmonary vascular disease
• Epilepsy with history of seizures
• Diabetes mellitus
• Females who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control
• Currently taking psychoactive prescription medication on a regular basis
• More than 20% outside the upper or lower range of ideal body weight according to Metropolitan Life height and weight table

Psychiatric Exclusion Criteria

• Current or past history of meeting DSM-IV criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I or II Disorder.
• Current severe Obsessive-Compulsive Disorder, Dysthymic Disorder, or Panic Disorder.
• Current or past history within the last 5 years of meeting DSM-IV criteria for alcohol or drug dependence (excluding caffeine and nicotine) or severe major depression.
• Have a first or second degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I or II disorder.
• Currently meets DSM-IV criteria for Dissociative Disorder, Anorexia Nervosa, Bulimia Nervosa, or other psychiatric conditions judged to be incompatible with establishment of rapport or safe exposure to salvinorin A.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Salvinorin A	Drug: Salvinorin A; This is an initial dose ranging study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hallucinogen Rating Scale	Approximately 1 hour after drug administration

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Study Director: Matthew W Johnson, Ph.D., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 15, 2009
• First Submitted That Met QC Criteria: October 15, 2009
• First Posted (Estimate): October 16, 2009

Study Record Updates

• Last Update Posted (Estimate): March 24, 2014
• Last Update Submitted That Met QC Criteria: March 21, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Healthy volunteers are being studied to evaluate the subject-rated, behavioral, and abuse liability effects of salvinorin A
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Psychotropic Drugs; Hallucinogens; Salvinorin A
• Other Study ID Numbers: NA_00009081